|Primary research questions|
Is the intervention feasible and acceptable to staff and participants?|
• Is the time commitment required for staff to monitor the intervention and participants to partake in the intervention feasible?
• Are there any environmental barriers to completion of the intervention?
• Is the content of the intervention acceptable to participants and staff?
• Do the participants adhere to the intervention and what adherence issues arise?
• What are the components of usual care for participants allocated to the control group?
Are the outcome measures feasible and acceptable to participants?|
• What is the required time and number of visits required to collect each outcome from participants?
• Are the outcome measures acceptable to participants?
• What is the level of missing data within the self-reported outcome measures?
• What is the feasibility of collecting health economic data (i.e. sources used and time taken)?
What is the required sample size for a definitive RCT?|
• What is the baseline score and variability of the primary outcome measure among participants?
• What is the estimated effect size and variance for the primary outcome measure?
• What are the recruitment and attrition rates for nursing homes and participants? Do these rates differ between the intervention and control groups?
|Secondary research questions|
What are the preliminary clinical outcomes and cost-effectiveness of the intervention compared to the control group?|
• What are the estimated outcomes of the intervention in comparison with the control group and are these sustained at 12-month follow-up?
• What are the costs of the intervention in comparison to costs in the control group?